title: The impact of the Harmonic FOCUS™ on complications in thyroid surgery: a prospective multicenter study.
abstract: In recent years, newer tools have been developed and used in thyroid surgery. This study compared patients with multinodular goiter undergoing thyroidectomy using the Harmonic FOCUS™ with patients undergoing the clamp-and-tie technique. Medical records of 268 patients with multinodular goiter undergoing thyroidectomy from December 2006 to July 2011 in two centers in Italy, the Department of Surgery of Pisa and the General Surgery Unit of Grosseto, were prospectively evaluated. Patients were divided into group A (Harmonic FOCUS™ Shear), and group B (clamp-and-tie technique). Patient demographics and specific end points analyzed included age, sex, diagnosis, thyroid gland volume, operative time, complications, need for clips and hemostatic agents, need for suction balloon, postoperative blood loss, and postoperative hospital length of stay. 141 patients were included in group A, and 127 patients were included in group B. The two groups were similar in age, sex ratio, indication for surgery, and thyroid volume. Mean operative time was significantly shorter with the Harmonic FOCUS™ Shear (51.8 min) than with the clamp-and-tie technique (70.9 min). The mean postoperative amount obtained from the suction balloon was similar. Vascular clips were needed significantly more frequently in group A (26.2 %) than in group B (12.5 %), whereas the need for hemostatic agents was significantly reduced in group A (4.2 %) compared with group B (14.9 %). The decision to leave a suction drain at the end of the operation occurred significantly more frequently in group B (96 %) than in group A (78 %). Mean postoperative hospital length of stay was 2.02 days in group A compared with 3.1 days in group B, which was significant. No definitive postoperative complications were documented in either group, except a higher rate, but not statistically significant, of permanent hypoparathyroidism in group B versus Group A. Transient laryngeal nerve injury was similar in both groups, whereas transient hypoparathyroidism occurred more frequently in Group B (4.7 %) than in Group A (2.4 %). Harmonic FOCUS device was significantly associated with lower rate of postoperative transient hypocalcemia, decreased operative time, shorter hospitalization, and lesser need for hemostatic agents and postoperative drain balloon. These results might be considered "indirect" money-saving factors, despite the cost of the device, especially in countries where the cost of thyroidectomy is influenced also by the hospital length of stay.
authors.affiliation: Department of Surgery, University of Pisa, Via Paradisa 2, Ed. 30A 2° piano, 56100, Pisa, Italy, gmaterazzi@yahoo.com.
authors.forename: Gabriele
authors.initials: G
authors.lastname: Materazzi
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Caravaglios
authors.forename: Valeria
authors.initials: V
authors.lastname: Matteucci
authors.forename: Aleksandr
authors.initials: A
authors.lastname: Aghababyan
authors.forename: Mario
authors.initials: M
authors.lastname: Miccoli
authors.forename: Paolo
authors.initials: P
authors.lastname: Miccoli
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006044:Goiter, Nodular / Q000601:surgery*; D006801:Humans; D007558:Italy; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D011446:Prospective Studies; D013965:Thyroidectomy / Q000009:adverse effects* / Q000295:instrumentation*; D016896:Treatment Outcome; D059708:Ultrasonic Surgical Procedures / Q000009:adverse effects* / Q000295:instrumentation*